Category lists following implementation of the Windsor Framework Further to my previous post, the...
MHRA category lists following implementation of the Windsor Framework - an early Christmas present?
On Friday 20 December 2024 the MHRA have released the category lists following implementation of the Windsor Framework. This can be found at the link below:
The MHRA did promise a list of category 1 products (that will happen automatically from 01 January 2025), and have done so, but just as everyone is on annual leave for Christmas!
All new marketing authorisation (MA) applications and existing authorised products will be assigned to Category 1 or Category 2, and the MHRA categories are defined as follows:
- Category 1: Medicines that previously fell within the mandatory or optional scope of the EU’s Centralised Procedure will be designated as ‘Category 1’. Category 1 includes generic, hybrid or biosimilar products of Category 1 reference products which have been authorised by the MHRA or centrally by the EU regardless of whether the centralised procedure was used for the generic, hybrid or biosimilar application in the EU (see section 4.1 of the UK-wide licensing guidance of the UK-wide licensing guidance). The rules for this category largely mirror those for medicines presently covered by GB only licences (these have a PLGB prefix). Category 1 products will be authorised by the MHRA in accordance with UK law on a UK-wide basis.
- Category 2: All products that do not fall within the scope of Category 1 will be Category 2 products (see section 4.2 of the UK-wide licensing guidance). The rules for this category largely mirror those for the medicines presently covered by a UK-wide licences (these have a ‘PL’ prefix). Category 2 products will be authorised by the MHRA in accordance with UK law and applicable EU law on a UK-wide basis.
These categories are needed to be clear which rules apply for UK authorisations. It is therefore important to know which category your medicine sits in, so that you know which actions need to be taken and by when. Most companies should have been looking at this already and so should know which MHRA category their drugs sit under. But as always, it is worth checking to make sure that you and the regulator are aligned. So, on Christmas week, Quality, Regulatory and Pharmacovigilance workers will be trawling through this list, to check to see if it matches what they previously thought.
As stated in the above categorisation, the MHRA guidance on ‘UK-Wide Licensing for Human Medicines’ gives detailed information on the implementation of the changes to the licensing of medicines (post Windsor Framework), including details of the categorisation:
Any issues or questions that are not in the MRHA Q&A, then I suggest that you contact the MHRA as soon as possible to discuss.
NB All guidance from the MHRA on the Windsor Framework can be found at the following link, for the ‘MHRA Windsor Framework Hub’:
